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Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy

Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Irritable Bowel Syndrome

Intervention: alosetron (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

Summary

The purpose of this study is to compare the safety and effectiveness of as needed versus fixed dosing of an investigational medication for women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.

Clinical Details

Official title: A 12-Week, Randomized, Double-Blind, Placebo- Controlled Study of PRN BID and Fixed Dosing Regimens of Alosetron in Female Subjects With Severe Diarrhea-Predominant Irritable Bowel Syndrome Who Have Failed Conventional Therapy

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Subject self assessment of improvement between treatment groups using the IBS Global Improvement Scale; comparison of safety and tolerability between treatment groups with respect to adverse events & laboratory abnormalities.

Secondary outcome: Comparison of treatment groups with respect to subject relief of IBS pain & discomfort; lower GI symptoms, changes in quality of life, lost workplace productivity, & lost household/leisure activity, & subject satisfaction with assigned study drug.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).

- Failed conventional therapy.

- Willing to make daily calls on a touch-tone telephone.

Exclusion criteria:

- History of or current chronic or severe constipation.

- Bloody diarrhea, abdominal pain with rectal bleeding.

- Thrombophlebitis.

- Abnormal thyroid stimulating hormone (TSH) value.

- Alcohol and/or substance abuse within past two years.

- Pregnant or lactating.

- History/treatment of malignancy within past five years.

Locations and Contacts

GSK Clinical Trials Call Center, Tallassee, Alabama 36078, United States

GSK Clinical Trials Call Center, Pell City, Alabama 35128, United States

GSK Clinical Trials Call Center, Huntsville, Alabama 35801, United States

GSK Clinical Trials Call Center, Birmingham, Alabama 35242, United States

GSK Clinical Trials Call Center, Mobile, Alabama 36693, United States

GSK Clinical Trials Call Center, Tucson, Arizona 85712, United States

GSK Clinical Trials Call Center, Oro Valley, Arizona 85739, United States

GSK Clinical Trials Call Center, North Little Rock, Arkansas 72117, United States

GSK Clinical Trials Call Center, Little Rock, Arkansas 72205, United States

GSK Clinical Trials Call Center, Fresno, California 93720, United States

GSK Clinical Trials Call Center, Orange, California 92868, United States

GSK Clinical Trials Call Center, Van Nuys, California 91405, United States

GSK Clinical Trials Call Center, Concord, California 94520, United States

GSK Clinical Trials Call Center, San Francisco, California 94114, United States

GSK Clinical Trials Call Center, Encinitas, California 92024, United States

GSK Clinical Trials Call Center, Beverly Hills, California 90211, United States

GSK Clinical Trials Call Center, San Diego, California 92108, United States

GSK Clinical Trials Call Center, San Diego, California 92120, United States

GSK Clinical Trials Call Center, Torrance, California 90505, United States

GSK Clinical Trials Call Center, San Francisco, California 94117, United States

GSK Clinical Trials Call Center, Los Angeles, California 90035, United States

GSK Clinical Trials Call Center, Roseville, California 95661, United States

GSK Clinical Trials Call Center, Carlsbad, California 92008, United States

GSK Clinical Trials Call Center, San Diego, California 92103, United States

GSK Clinical Trials Call Center, San Francisco, California 94115, United States

GSK Clinical Trials Call Center, San Diego, California 92120, United States

GSK Clinical Trials Call Center, Longmont, Colorado 80501, United States

GSK Clinical Trials Call Center, Littleton, Colorado 80120, United States

GSK Clinical Trials Call Center, Centennial, Colorado 80112, United States

GSK Clinical Trials Call Center, Colorado Springs, Colorado 80909, United States

GSK Clinical Trials Call Center, Bristol, Connecticut 06010, United States

GSK Clinical Trials Call Center, Washington, District of Columbia 20010, United States

GSK Clinical Trials Call Center, Clearwater, Florida 33765, United States

GSK Clinical Trials Call Center, Stuart, Florida 34996, United States

GSK Clinical Trials Call Center, Jacksonville, Florida 32204, United States

GSK Clinical Trials Call Center, DeLand, Florida 32720, United States

GSK Clinical Trials Call Center, Clearwater, Florida 33756, United States

GSK Clinical Trials Call Center, North Miami Beach, Florida 33162, United States

GSK Clinical Trials Call Center, Zephyrhills, Florida 33540, United States

GSK Clinical Trials Call Center, Melbourne, Florida 32901, United States

GSK Clinical Trials Call Center, Gainesville, Florida 32607, United States

GSK Clinical Trials Call Center, Belleair Bluffs, Florida 33770, United States

GSK Clinical Trials Call Center, Spring Hill, Florida 34608, United States

GSK Clinical Trials Call Center, Hollywood, Florida 33021, United States

GSK Clinical Trials Call Center, Miami, Florida 33156, United States

GSK Clinical Trials Call Center, Boca Raton, Florida 33428, United States

GSK Clinical Trials Call Center, Kissimmee, Florida 34741, United States

GSK Clinical Trials Call Center, Jacksonville, Florida 32209, United States

GSK Clinical Trials Call Center, Jacksonville, Florida 32256, United States

GSK Clinical Trials Call Center, Bradenton, Florida 34209, United States

GSK Clinical Trials Call Center, Blue Ridge, Georgia 30513, United States

GSK Clinical Trials Call Center, Atlanta, Georgia 30339, United States

GSK Clinical Trials Call Center, Fayetteville, Georgia 30214, United States

GSK Clinical Trials Call Center, Atlanta, Georgia 30328, United States

GSK Clinical Trials Call Center, Rome, Georgia 30165, United States

GSK Clinical Trials Call Center, Savannah, Georgia 31404, United States

GSK Clinical Trials Call Center, Marietta, Georgia 30067, United States

GSK Clinical Trials Call Center, Dunwoody, Georgia 30338, United States

GSK Clinical Trials Call Center, Coeur d Alene, Idaho 83814, United States

GSK Clinical Trials Call Center, Boise, Idaho 83705, United States

GSK Clinical Trials Call Center, Boise, Idaho 83705, United States

GSK Clinical Trials Call Center, Libertyville, Illinois 60048, United States

GSK Clinical Trials Call Center, Oakbrook Terrace, Illinois 60181, United States

GSK Clinical Trials Call Center, Peoria, Illinois 61602, United States

GSK Clinical Trials Call Center, Rockford, Illinois 61107, United States

GSK Clinical Trials Call Center, Morton, Illinois 61550, United States

GSK Clinical Trials Call Center, Moline, Illinois 61265, United States

GSK Clinical Trials Call Center, Chicago, Illinois 60637, United States

GSK Clinical Trials Call Center, Chicago, Illinois 60612, United States

GSK Clinical Trials Call Center, Evanston, Illinois 60201, United States

GSK Clinical Trials Call Center, Glenview, Illinois 60025, United States

GSK Clinical Trials Call Center, Evansville, Indiana 47714, United States

GSK Clinical Trials Call Center, Jeffersonville, Indiana 47130, United States

GSK Clinical Trials Call Center, Indianapolis, Indiana 46208, United States

GSK Clinical Trials Call Center, Indianapolis, Indiana 46237, United States

GSK Clinical Trials Call Center, Clive, Iowa 50325, United States

GSK Clinical Trials Call Center, Haysville, Kansas 67203, United States

GSK Clinical Trials Call Center, Wichita, Kansas 67203, United States

GSK Clinical Trials Call Center, Kansas City, Kansas 66160, United States

GSK Clinical Trials Call Center, Lexington, Kentucky 40504, United States

GSK Clinical Trials Call Center, Florence, Kentucky 41042, United States

GSK Clinical Trials Call Center, Lexington, Kentucky 40536, United States

GSK Clinical Trials Call Center, Shreveport, Louisiana 71103, United States

GSK Clinical Trials Call Center, New Orleans, Louisiana 70112, United States

GSK Clinical Trials Call Center, Metairie, Louisiana 70006, United States

GSK Clinical Trials Call Center, Covington, Louisiana 70433, United States

GSK Clinical Trials Call Center, Bastrop, Louisiana 71220, United States

GSK Clinical Trials Call Center, Lafayette, Louisiana 70506, United States

GSK Clinical Trials Call Center, Lanham, Maryland 20706, United States

GSK Clinical Trials Call Center, Baltimore, Maryland 21215, United States

GSK Clinical Trials Call Center, Severna Park, Maryland 21146, United States

GSK Clinical Trials Call Center, Annapolis, Maryland 21401, United States

GSK Clinical Trials Call Center, Oxon Hill, Maryland 20745, United States

GSK Clinical Trials Call Center, Towson, Maryland 21204, United States

GSK Clinical Trials Call Center, Baltimore, Maryland 21229, United States

GSK Clinical Trials Call Center, Wheaton, Maryland 20906, United States

GSK Clinical Trials Call Center, Towson, Maryland 21204, United States

GSK Clinical Trials Call Center, Burlington, Massachusetts 01805, United States

GSK Clinical Trials Call Center, Farmington Hills, Michigan 48334, United States

GSK Clinical Trials Call Center, Livonia, Michigan 48152, United States

GSK Clinical Trials Call Center, Saginaw, Michigan 48602, United States

GSK Clinical Trials Call Center, Petoskey, Michigan 49770, United States

GSK Clinical Trials Call Center, Arden Hills, Minnesota 55126, United States

GSK Clinical Trials Call Center, Brooklyn Center, Minnesota 55430, United States

GSK Clinical Trials Call Center, Chesterfield, Missouri 63017, United States

GSK Clinical Trials Call Center, Omaha, Nebraska 68144, United States

GSK Clinical Trials Call Center, Lincoln, Nebraska 68503, United States

GSK Clinical Trials Call Center, Henderson, Nevada 89014, United States

GSK Clinical Trials Call Center, Las Vegas, Nevada 89119, United States

GSK Clinical Trials Call Center, Oakhurst, New Jersey 07755, United States

GSK Clinical Trials Call Center, Berlin, New Jersey 08009, United States

GSK Clinical Trials Call Center, Blackwood, New Jersey 08012, United States

GSK Clinical Trials Call Center, Passaic, New Jersey 07055, United States

GSK Clinical Trials Call Center, Cedar Knolls, New Jersey 07927, United States

GSK Clinical Trials Call Center, Willingboro, New Jersey 08046, United States

GSK Clinical Trials Call Center, South Bound Brook, New Jersey 08880, United States

GSK Clinical Trials Call Center, Hillsborough, New Jersey 08844, United States

GSK Clinical Trials Call Center, Albuquerque, New Mexico 87106, United States

GSK Clinical Trials Call Center, Binghamton, New York 13903, United States

GSK Clinical Trials Call Center, Pittsford, New York 14534, United States

GSK Clinical Trials Call Center, Endwell, New York 13760, United States

GSK Clinical Trials Call Center, Pomona, New York 10970, United States

GSK Clinical Trials Call Center, Albany, New York 12205, United States

GSK Clinical Trials Call Center, Jacksonville, North Carolina 28546, United States

GSK Clinical Trials Call Center, Charlotte, North Carolina 28262, United States

GSK Clinical Trials Call Center, Cary, North Carolina 27511, United States

GSK Clinical Trials Call Center, Wilmington, North Carolina 28412, United States

GSK Clinical Trials Call Center, Raleigh, North Carolina 27609, United States

GSK Clinical Trials Call Center, Wilmington, North Carolina 28401, United States

GSK Clinical Trials Call Center, Gastonia, North Carolina 28054, United States

GSK Clinical Trials Call Center, Greenville, North Carolina 27858, United States

GSK Clinical Trials Call Center, Greensboro, North Carolina 27403, United States

GSK Clinical Trials Call Center, Bellbrook, Ohio 45305, United States

GSK Clinical Trials Call Center, Columbus, Ohio 43207, United States

GSK Clinical Trials Call Center, Wadsworth, Ohio 44281, United States

GSK Clinical Trials Call Center, Columbus, Ohio 43215, United States

GSK Clinical Trials Call Center, Cincinnati, Ohio 45236, United States

GSK Clinical Trials Call Center, Tulsa, Oklahoma 74135, United States

GSK Clinical Trials Call Center, Eugene, Oregon 97401, United States

GSK Clinical Trials Call Center, Portland, Oregon 97210, United States

GSK Clinical Trials Call Center, Portland, Oregon 97225, United States

GSK Clinical Trials Call Center, Levittown, Pennsylvania 19057, United States

GSK Clinical Trials Call Center, Morrisville, Pennsylvania 19067, United States

GSK Clinical Trials Call Center, Bensalem, Pennsylvania 19020, United States

GSK Clinical Trials Call Center, Philadelphia, Pennsylvania 19148, United States

GSK Clinical Trials Call Center, Temple, Pennsylvania 19560, United States

GSK Clinical Trials Call Center, Perkasie, Pennsylvania 18944, United States

GSK Clinical Trials Call Center, Penndel, Pennsylvania 19047, United States

GSK Clinical Trials Call Center, Duncansville, Pennsylvania 16635, United States

GSK Clinical Trials Call Center, Pittsburgh, Pennsylvania 15218, United States

GSK Clinical Trials Call Center, Stoneboro, Pennsylvania 16153, United States

GSK Clinical Trials Call Center, Feasterville-Trevose, Pennsylvania 19053, United States

GSK Clinical Trials Call Center, Philadelphia, Pennsylvania 19107, United States

GSK Clinical Trials Call Center, Philadelphia, Pennsylvania 19106, United States

GSK Clinical Trials Call Center, Wallingford, Pennsylvania 19063, United States

GSK Clinical Trials Call Center, Sellersville, Pennsylvania 18960, United States

GSK Clinical Trials Call Center, Anderson, South Carolina 29621, United States

GSK Clinical Trials Call Center, Summerville, South Carolina 29485, United States

GSK Clinical Trials Call Center, Charleston, South Carolina 29407, United States

GSK Clinical Trials Call Center, Sioux Falls, South Dakota 57105, United States

GSK Clinical Trials Call Center, Johnson City, Tennessee 37601, United States

GSK Clinical Trials Call Center, Kingsport, Tennessee 37660, United States

GSK Clinical Trials Call Center, Bristol, Tennessee 37620, United States

GSK Clinical Trials Call Center, Clarksville, Tennessee 37043, United States

GSK Clinical Trials Call Center, Nashville, Tennessee 37205, United States

GSK Clinical Trials Call Center, Knoxville, Tennessee 37920, United States

GSK Clinical Trials Call Center, Jackson, Tennessee 38305, United States

GSK Clinical Trials Call Center, Pasadena, Texas 77505, United States

GSK Clinical Trials Call Center, Conroe, Texas 77304, United States

GSK Clinical Trials Call Center, Austin, Texas 78758, United States

GSK Clinical Trials Call Center, San Antonio, Texas 78205, United States

GSK Clinical Trials Call Center, Dallas, Texas 75230, United States

GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States

GSK Clinical Trials Call Center, Houston, Texas 77024, United States

GSK Clinical Trials Call Center, Sugar Land, Texas 77478, United States

GSK Clinical Trials Call Center, Conroe, Texas 77304, United States

GSK Clinical Trials Call Center, Houston, Texas 77024, United States

GSK Clinical Trials Call Center, North Richland Hills, Texas 76180, United States

GSK Clinical Trials Call Center, Humble, Texas 77338, United States

GSK Clinical Trials Call Center, The Woodlands, Texas 77381, United States

GSK Clinical Trials Call Center, Salt Lake City, Utah 84132, United States

GSK Clinical Trials Call Center, Weber City, Virginia 24290, United States

GSK Clinical Trials Call Center, Virginia Beach, Virginia 23455, United States

GSK Clinical Trials Call Center, Richmond, Virginia 23294, United States

GSK Clinical Trials Call Center, Danville, Virginia 24541, United States

GSK Clinical Trials Call Center, Norfolk, Virginia 23507, United States

GSK Clinical Trials Call Center, Norfolk, Virginia 23502, United States

GSK Clinical Trials Call Center, Christiansburg, Virginia 24073, United States

GSK Clinical Trials Call Center, Norfolk, Virginia 23502, United States

GSK Clinical Trials Call Center, Gig Harbor, Washington 98335, United States

GSK Clinical Trials Call Center, Tacoma, Washington 98405, United States

GSK Clinical Trials Call Center, Bellevue, Washington 98004, United States

GSK Clinical Trials Call Center, Madison, Wisconsin 53792, United States

GSK Clinical Trials Call Center, La Crosse, Wisconsin 54601, United States

Additional Information

Starting date: June 2003
Last updated: September 24, 2007

Page last updated: June 20, 2008

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